There Are no Specific Conditions Under StudyNCT02430454
Impact of Bed Availability and Cognitive Load on Intensive Care Unit Bed Allocation: a Vignette-based Clinical Trial
A study testing Increased cognitive load in people with There Are no Specific Conditions Under Study and This Study Evaluates the Clinical Decision-Making Associated With Intensive Care Units Rationing, run by University of Sao Paulo General Hospital.
Trial summary
Decisions about ICU beds allocations are made everyday, specially in countries with scarcity of ICU beds, such as Brazil. ICU triage, most of the time, is not structured, which may lead to faulty decision making, possibly leading to bad clinical outcomes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- There Are no Specific Conditions Under Study, This Study Evaluates the Clinical Decision-Making Associated With Intensive Care Units Rationing
- What is being tested?
- Increased cognitive load
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Intensive care unit doctors participating in specialty email lists
Who cannot join
- Consent not provided
About this study
Official title: Vignette-based Randomized Controlled Trial of the Decision Making Process of Bed Allocation in the Intensive Care Unit: Impact of Bed Availability and Cognitive Load.
Decisions about ICU beds allocations are made everyday, specially in countries with scarcity of ICU beds, such as Brazil. ICU triage, most of the time, is not structured, which may lead to faulty decision making, possibly leading to bad clinical outcomes. It has been shown that external factors may influence the decision making process. The investigators intend to evaluate the impact of bed availability and cognitive load on the ICU bed allocation process by submitting groups of individuals to a vignette based randomized controlled trial simulating conditions with or without increased cognitive load and conditions with or without scarcity of ICU beds.
Read the detailed description
Vignettes will be constructed based on consecutive patients for whom ICU bed was solicited. Vignettes will be validated through the evaluation of 8 experts in situations with or without bed scarcity. Vignettes with more than 80% concordance on ICU disposition (admission or refusion) will be used in the trial.
Intensive care doctors in Brazil will be asked to answer an online questionnaire with demographic characteristics and randomized to one of two groups. The experimental group will be submitted to increased cognitive load conditions, meaning that they will be encouraged to give their first impression on the vignettes, will have a time limit to answer the questions and will have popups with sound and videos, with the purpose to distract the respondents. The control group will be encouraged to think thoroughly and will have no time limit or distractions.
Vignettes will be presented, randomly, in conditions with or without scarcity of ICU beds to both groups. So, respondents with and without increased cognitive load will evaluate vignettes in conditions with and without scarcity of ICU beds.
- Conditions
- There Are no Specific Conditions Under Study, This Study Evaluates the Clinical Decision-Making Associated With Intensive Care Units Rationing
- Being tested
- Increased cognitive load
- Keywords
- ICU, decision making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased cognitive loadBehavioural
simulated conditions to increase cognitive load: encourage first impression, time-limit, distractions
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Subjected to increased cognitive load Receives: Behavioral: Increased cognitive load |
| Control | No intervention | Not subjected to increased cognitive load |
What is being measured
The primary outcome is the main question the study is designed to answer.
simulated ICU admission rates
difference on simulated ICU admission rates between the experimental and control groups, comparing to the expected allocation (designated by the experts that validated the vignettes and Society of Critical Care Medicine priority rank)
Measured: 24 hours
Secondary outcomes (1)
Time to complete the questionnaire
difference on time to complete the questionnaire between the two groups
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for There Are no Specific Conditions Under StudyStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, João Gabriel Rosa Ramos, University of Sao Paulo General Hospital
- Investigators
- Joao G Ramos, MD, Principal investigator, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430454
- Sponsor's protocol ID
- 43084815.0.0000.0068
- Status last verified
- Jan 2016
- First submitted
- 14 Apr 2015
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vignette-based Randomized Controlled Trial of the Decision Making Process of Bed Allocation in the Intensive Care Unit: Impact of Bed Availability and Cognitive Load.
- ClinicalTrials.gov ID
- NCT02430454
- Acronym / sponsor ID
- 43084815.0.0000.0068
- Conditions
- There Are no Specific Conditions Under Study, This Study Evaluates the Clinical Decision-Making Associated With Intensive Care Units Rationing
- Keywords
- ICU, decision making
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Decisions about ICU beds allocations are made everyday, specially in countries with scarcity of ICU beds, such as Brazil. ICU triage, most of the time, is not structured, which may lead to faulty decision making, possibly leading to bad clinical outcomes. It has been shown that external factors may influence the decision making process. The investigators intend to evaluate the impact of bed availability and cognitive load on the ICU bed allocation process by submitting groups of individuals to a vignette based randomized controlled trial simulating conditions with or without increased cognitive load and conditions with or without scarcity of ICU beds.
Detailed description
Vignettes will be constructed based on consecutive patients for whom ICU bed was solicited. Vignettes will be validated through the evaluation of 8 experts in situations with or without bed scarcity. Vignettes with more than 80% concordance on ICU disposition (admission or refusion) will be used in the trial.
Intensive care doctors in Brazil will be asked to answer an online questionnaire with demographic characteristics and randomized to one of two groups. The experimental group will be submitted to increased cognitive load conditions, meaning that they will be encouraged to give their first impression on the vignettes, will have a time limit to answer the questions and will have popups with sound and videos, with the purpose to distract the respondents. The control group will be encouraged to think thoroughly and will have no time limit or distractions.
Vignettes will be presented, randomly, in conditions with or without scarcity of ICU beds to both groups. So, respondents with and without increased cognitive load will evaluate vignettes in conditions with and without scarcity of ICU beds.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Increased cognitive loadSubjected to increased cognitive load |
| Control | No intervention | –Not subjected to increased cognitive load |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Intensive care unit doctors participating in specialty email lists
Key exclusion criteria (1 listed)
- Consent not provided
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increased cognitive loadsimulated conditions to increase cognitive load: encourage first impression, time-limit, distractions | Behavioural | Experimental |
Primary outcome
simulated ICU admission rates
Time frame: 24 hours
difference on simulated ICU admission rates between the experimental and control groups, comparing to the expected allocation (designated by the experts that validated the vignettes and Society of Critical Care Medicine priority rank)
1 secondary outcome
Time to complete the questionnaire
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joao G Ramos, MD principal investigator
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Increased cognitive load in people with There Are no Specific Conditions Under Study and This Study Evaluates the Clinical Decision-Making Associated With Intensive Care Units Rationing, run by University of Sao Paulo General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
simulated ICU admission rates (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.